Sterile Procedural Trays, labeled as the following: a. GYN-URO LAPSCP CDS-LF b. ROBOTIC CDS...
FDA Device Recall #Z-1091-2023 — Class II — November 17, 2022
Recall Summary
| Recall Number | Z-1091-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 17, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 8,064 cases (12,425 units) |
Product Description
Sterile Procedural Trays, labeled as the following: a. GYN-URO LAPSCP CDS-LF b. ROBOTIC CDS c. GYN LAPAROSCOPY CDS-LF d. GYN LAPAROSCOPY e. GYN LAPAROSCOPY CDS f. UNIVERSAL ROBOTIC ORLANDO g. GYN ROBOTIC CDS h. GYN LAPAROSCOPY CDS-1 i. CUH GYN LAPAROSCOPY CDS j. CUH GEN/GYN ROBOTIC CDS k. LAVH CDS-LF l. GYN LAPAROSCOPY CDS-LF m. GYN LAPAROSCOPY CDS UCC-LF n. DAY SURG GYN LAP CDS o. GYN LAPAROSCOPY CDS p. DAVINCI HYSTERECTOMY CDS q. GYN LAP/ROBOTIC r. DAVINCI PACK-LF s. DAVINCI PACK-LF t. GYN LAPAROSCOPY PACK-LF u. ROBOTIC PACK v. GYN LAP - UNIV w. BASIC LAVH PACK x. GYN/LAPAROSCOPY PACK-LF y. LAPAROSCOPIC GYN PACK-LF z. DAVINCI PACK-LF aa. SCC GYN LAPAROSCOPY PACK bb. URO GYN PACK-LF cc. GYN LAPAROSCOPY PACK dd. TUBAL PACK ee. GYN LAP PACK-LF ff. LAVH PACK gg. GYN LAPAROSCOPY-LF hh. LAVH PACK ii. PK-GYN-LAPAROSCOPY jj. MAJOR LAP PACK 2-LF kk. TUBAL PACK ll. GYN LAPAROSCOPY PACK-LF mm. PK, ROBOTICS-GYN nn. SVMMC GEN ROBOTIC PACK oo. SVMMC GYN ROBOTIC PACK pp. PACK, GYN-D&C qq. DA VINCI PROSTATE/COLPOPEXY rr. ROBOT PACK ss. PK, GYN-LAPAROSCOPY tt. LAPAROSCOPIC GYN PACK uu. DAVINCI PACK-RFD vv. GYN ROBOTIC PACK ww. LAVH PACK xx. ST. ANNE'S MULTI PORT PACK yy. LAVH PACK zz. SOUTH SC RFT GYN LAP PACK aaa. GYN LAPAROSCOPY PACK bbb. LITHOTOMY PENILE PACK ccc. DAVINCI GENERAL PACK ddd. DAVINCI GYN PACK eee. DAVINCI GYN PACK fff. ROBOTIC PROSTATE PACK ggg. GYN ROBOTIC PACK-LF hhh. SCRIPPS SW ROBOTIC PACK iii. GYN LITHOTOMY PACK jjj. GYN LAPAROSCOPY PACK kkk. DEACONESS PELVIC LAP PACK lll. WOMENS ROBOT PACK mmm. GYN LAPAROSCOPY PACK-LF nnn. MAJOR GYN PACK ooo. GYN LAPAROSCOPY PACK ppp. TUBAL PACK-LF qqq. PK, GYN-LAPAROSCOPY rrr. LAVH PACK sss. LAPAROTOMY PACK ttt. URO/GEN ROBOTIC PACK uuu. BASIC ROBOTIC PACK vvv. LAPAROSCOPIC GYN PACK www. PK, ROBOTICS-GYN xxx. PQ CHG CTRY GYN LAP PK yyy. GYN DAVINCI PACK zzz. ROBOT GYN SHARED aaaa. PK, ROBOTICS-GEN bbbb. DAVINCI PACK cccc. ROBOTIC GYN PACK dddd. ROBOTICS PACK eeee. PK- ROBOTICS ffff. GYN LAPAROSCOPY gggg. GU ROBOTIC PACK hhhh. GYN PACK iiii. BASIC GYN PACK jjjj. BWH GYN ROBOTICS PACK kkkk. BWH GU ROBOTICS PACK llll. URO GYN PACK mmmm. GYN LAP PACK nnnn. GYN LAPAROSCOPY oooo. ROBOTIC pppp. GYN ROBOTIC qqqq. CV ROBOTIC SET UP rrrr. GYN LAPAROSCOPY ssss. ROBOTIC LAVH tttt. ROBOTIC LAP CHOLE uuuu. GYN LAPAROSCOPY vvvv. GYN LAPAROSCOPY wwww. GYN ROBOTIC xxxx. GYN ENDOSCOPY-LF yyyy. GYN LAPAROSCOPY zzzz. LAP ROBOTIC aaaaa. TUBAL LIGATION CDS bbbbb. GYN LAPAROSCOPY ccccc. ROBOTIC GYN & GU ddddd. ROBOTIC eeeee. GYN LAPAROSCOPY fffff. ROBOT GYN ggggg. GYN LAPAROSCOPY hhhhh. FHWC ROBOTIC iiiii. GYN LAPAROSCOPY jjjjj. GYN LAPAROSCOPY kkkkk. ROBOTIC lllll. PELVISCOPY mmmmm. GENERAL ROBOT-TCN nnnnn. ROBOTICS ooooo. CVOR ROBOT ppppp. GU-GEN ROBOTIC qqqqq. FLOYD LAP GYN rrrrr. GYN ROBOTIC sssss. GYN LAPAROSCOPY CDS ttttt. LAP TUBAL uuuuu. DAVINCI GENERAL vvvvv. DAVINCI LOW ANTERIOR RESECTION wwwww. GYN xxxxx. PELVISCOPY PACK yyyyy. GYN LAPAROSCOPY STD PACK-LF zzzzz. LAP GYN PACK-LF
Reason for Recall
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Lot / Code Information
a. GYN-URO LAPSCP CDS-LF, Item Number: CDS981583U, Case UDI/GTIN: 40195327209767, Unit UDI/GTIN: 10195327209766, Lot Number: 22JBE255; b. ROBOTIC CDS, Item Number: CDS981882W, Case UDI/GTIN: 40195327144983, Unit UDI/GTIN: 10195327144982, Lot Number: 22IBR176; c. GYN LAPAROSCOPY CDS-LF, Item Number: CDS981988I, Case UDI/GTIN: 40193489744164, Unit UDI/GTIN: 10193489744163, Lot Number: 22KBF564,22JBV989; d. GYN LAPAROSCOPY, Item Number: CDS982032Y, Case UDI/GTIN: 40195327248858, Unit UDI/GTIN: 10195327248857, Lot Number: 22JBE743; e. GYN LAPAROSCOPY CDS, Item Number: CDS982371G, Case UDI/GTIN: 40193489209397, Unit UDI/GTIN: 10193489209396, Lot Number: 22JBU375,22JBU054; f. UNIVERSAL ROBOTIC ORLANDO, Item Number: CDS982857K, Case UDI/GTIN: 40193489927864, Unit UDI/GTIN: 10193489927863, Lot Number: 22IBA586; g. GYN ROBOTIC CDS, Item Number: CDS982888M, Case UDI/GTIN: 40195327110698, Unit UDI/GTIN: 10195327110697, Lot Number: 22JBK498; h. GYN LAPAROSCOPY CDS-1, Item Number: CDS982892F, Case UDI/GTIN: 40889942216926, Unit UDI/GTIN: 10889942216925, Lot Number: 22JBI848; i. CUH GYN LAPAROSCOPY CDS, Item Number: CDS983206L, Case UDI/GTIN: 40195327164592, Unit UDI/GTIN: 10195327164591, Lot Number: 22JBM358; j. CUH GEN/GYN ROBOTIC CDS, Item Number: CDS983375L, Case UDI/GTIN: 40195327164547, Unit UDI/GTIN: 10195327164546, Lot Number: 22JBI299; k. LAVH CDS-LF, Item Number: CDS983868F, Case UDI/GTIN: 40889942017233, Unit UDI/GTIN: 10889942017232, Lot Number: 22JDB254; l. GYN LAPAROSCOPY CDS-LF, Item Number: CDS984536J, Case UDI/GTIN: 40193489831345, Unit UDI/GTIN: 10193489831344, Lot Number: 22IDB843; m. GYN LAPAROSCOPY CDS UCC-LF, Item Number: CDS984684D, Case UDI/GTIN: 40193489571364, Unit UDI/GTIN: 10193489571363, Lot Number: 22JBR850,22JBE881,22IBV318; n. DAY SURG GYN LAP CDS, Item Number: CDS984996K, Case UDI/GTIN: 40195327175772, Unit UDI/GTIN: 10195327175771, Lot Number: 22JBD508; o. GYN LAPAROSCOPY CDS, Item Number: CDS985217J, Case UDI/GTIN: 40195327110841, Unit UDI/GTIN: 10195327110840, Lot Number: 22KBC728,22IBA646; p. DAVINCI HYSTERECTOMY CDS, Item Number: CDS985344D, Case UDI/GTIN: 40193489905527, Unit UDI/GTIN: 10193489905526, Lot Number: 22IBR928,22IBS195; q. GYN LAP/ROBOTIC, Item Number: CDS985466G, Case UDI/GTIN: 40195327043118, Unit UDI/GTIN: 10195327043117, Lot Number: 22JDB080; r. DAVINCI PACK-LF, Item Number: DYNJ0046535D, Case UDI/GTIN: 40195327095667, Unit UDI/GTIN: 10195327095666, Lot Number: 22JMH534; s. DAVINCI PACK-LF, Item Number: DYNJ0161960F, Case UDI/GTIN: 40195327171521, Unit UDI/GTIN: 10195327171520, Lot Number: 22IDB492,22IDA146; t. GYN LAPAROSCOPY PACK-LF, Item Number: DYNJ01910K, Case UDI/GTIN: 40193489962803, Unit UDI/GTIN: 10193489962802, Lot Number: 22IBU972; u. ROBOTIC PACK, Item Number: DYNJ02457K, Case UDI/GTIN: 40195327108923, Unit UDI/GTIN: 10195327108922, Lot Number: 22JMG295; v. GYN LAP - UNIV, Item Number: DYNJ0375503L, Case UDI/GTIN: 40193489943215, Unit UDI/GTIN: 10193489943214, Lot Number: 22JBP432; w. BASIC LAVH PACK, Item Number: DYNJ0378714G, Case UDI/GTIN: 40889942435266, Unit UDI/GTIN: 10889942435265, Lot Number: 22IBI287; x. GYN/LAPAROSCOPY PACK-LF, Item Number: DYNJ0395118K, Case UDI/GTIN: 40195327063895, Unit UDI/GTIN: 10195327063894, Lot Number: 22JBS258; y. LAPAROSCOPIC GYN PACK-LF, Item Number: DYNJ04718T, Case UDI/GTIN: 40193489444873, Unit UDI/GTIN: 10193489444872, Lot Number: 22JMC979; z. DAVINCI PACK-LF, Item Number: DYNJ0556546D, Case UDI/GTIN: 40195327271726, Unit UDI/GTIN: 10195327271725, Lot Number: 22JMI211; aa. SCC GYN LAPAROSCOPY PACK, Item Number: DYNJ16604R, Case UDI/GTIN: 40195327218615, Unit UDI/GTIN: 10195327218614, Lot Number: 22JMB584; bb. URO GYN PACK-LF, Item Number: DYNJ17454M, Case UDI/GTIN: 40193489776028, Unit UDI/GTIN: 10193489776027, Lot Number: 22IBN968,22HBK091; cc. GYN LAPAROSCOPY PACK, Item Number: DYNJ30301D, Case UDI/GTIN: 40889942764953, Unit UDI/GTIN: 10889942764952, Lot Number: 22JBX986; dd. TUBAL PACK, Item Number: DYNJ30481G, Case UDI/GTIN: 40193489912891, Unit UDI/GTIN: 10193489912890, Lot Number: 22JMA315; ee. GYN LAP PACK-LF, Item Number: DYNJ32754M, Case UDI/GTIN: 40193489588980, Unit UDI/GTIN: 10193489588989, Lot Number: 22IMD300,22IMD302; ff. LAVH PACK, Item Number: DYNJ36508B, Case UDI/GTIN: 40889942715764, Unit UDI/GTIN: 10889942715763, Lot Number: 22JBJ622; gg. GYN LAPAROSCOPY-LF, Item Number: DYNJ36713B, Case UDI/GTIN: 40195327148035, Unit UDI/GTIN: 10195327148034, Lot Number: 22JBG940,22HBR656; hh. LAVH PACK, Item Number: DYNJ37785B, Case UDI/GTIN: 40888277792280, Unit UDI/GTIN: 10888277792289, Lot Number: 22IBK833; ii. PK-GYN-LAPAROSCOPY, Item Number: DYNJ42386D, Case UDI/GTIN: 40195327253340, Unit UDI/GTIN: 10195327253349, Lot Number: 22JMH924; jj. MAJOR LAP PACK 2-LF, Item Number: DYNJ42635D, Case UDI/GTIN: 40193489919425, Unit UDI/GTIN: 10193489919424, Lot Number: 22JBW532,22JBH135,22IBD371; kk. TUBAL PACK, Item Number: DYNJ42636, Case UDI/GTIN: 40888277003577, Unit UDI/GTIN: 10888277003576, Lot Number: 22KBA571; ll. GYN LAPAROSCOPY PACK-LF, Item Number: DYNJ42838B, Case UDI/GTIN: 40193489880374, Unit UDI/GTIN: 10193489880373, Lot Number: 22IBT573,22HBY144; mm. PK, ROBOTICS-GYN, Item Number: DYNJ43715B, Case UDI/GTIN: 40193489322911, Unit UDI/GTIN: 10193489322910, Lot Number: 22IBU770; nn. SVMMC GEN ROBOTIC PACK, Item Number: DYNJ43770L, Case UDI/GTIN: 40193489989992, Unit UDI/GTIN: 10193489989991, Lot Number: 22JBT938,22IBC524; oo. SVMMC GYN ROBOTIC PACK, Item Number: DYNJ43782K, Case UDI/GTIN: 40193489989893, Unit UDI/GTIN: 10193489989892, Lot Number: 22JBM498,22IBD372; pp. PACK, GYN-D&C, Item Number: DYNJ43931C, Case UDI/GTIN: 40193489431606, Unit UDI/GTIN: 10193489431605, Lot Number: 22JMD510; qq. DA VINCI PROSTATE/COLPOPEXY, Item Number: DYNJ44864S, Case UDI/GTIN: 40195327127627, Unit UDI/GTIN: 10195327127626, Lot Number: 22HBY159; rr. ROBOT PACK, Item Number: DYNJ45184F, Case UDI/GTIN: 40195327191475, Unit UDI/GTIN: 10195327191474, Lot Number: 22JBD483; ss. PK, GYN-LAPAROSCOPY, Item Number: DYNJ46271A, Case UDI/GTIN: 40193489338295, Unit UDI/GTIN: 10193489338294, Lot Number: 22IBS007; tt. LAPAROSCOPIC GYN PACK, Item Number: DYNJ47274L, Case UDI/GTIN: 40195327263943, Unit UDI/GTIN: 10195327263942, Lot Number: 22JMI249,22JMA188; uu. DAVINCI PACK-RFD, Item Number: DYNJ47762M, Case UDI/GTIN: 40195327105434, Unit UDI/GTIN: 10195327105433, Lot Number: 22JME004,22JMD998; vv. GYN ROBOTIC PACK, Item Number: DYNJ47766Q, Case UDI/GTIN: 40195327270002, Unit UDI/GTIN: 10195327270001, Lot Number: 22JDB952; ww. LAVH PACK, Item Number: DYNJ48599, Case UDI/GTIN: 40888277915115, Unit UDI/GTIN: 10888277915114, Lot Number: 22JBC120; xx. ST. ANNE'S MULTI PORT PACK, Item Number: DYNJ48638G, Case UDI/GTIN: 40195327109159, Unit UDI/GTIN: 10195327109158, Lot Number: 22IBP249; yy. LAVH PACK, Item Number: DYNJ49353, Case UDI/GTIN: 40888277846761, Unit UDI/GTIN: 10888277846760, Lot Number: 22IBN984; zz. SOUTH SC RFT GYN LAP PACK, Item Number: DYNJ50840A, Case UDI/GTIN: 40889942221371, Unit UDI/GTIN: 10889942221370, Lot Number: 22JMI259,22JMC606; aaa. GYN LAPAROSCOPY PACK, Item Number: DYNJ51102B, Case UDI/GTIN: 40193489985338, Unit UDI/GTIN: 10193489985337, Lot Number: 22JDB774; bbb. LITHOTOMY PENILE PACK, Item Number: DYNJ51161C, Case UDI/GTIN: 40889942493792, Unit UDI/GTIN: 10889942493791, Lot Number: 22JBH136,22HBR181; ccc. DAVINCI GENERAL PACK, Item Number: DYNJ51399J, Case UDI/GTIN: 40193489984492, Unit UDI/GTIN: 10193489984491, Lot Number: 22HDA632; ddd. DAVINCI GYN PACK, Item Number: DYNJ51400J, Case UDI/GTIN: 40193489984508, Unit UDI/GTIN: 10193489984507, Lot Number: 22IDA309; eee. DAVINCI GYN PACK, Item Number: DYNJ51400K, Case UDI/GTIN: 40195327277605, Unit UDI/GTIN: 10195327277604, Lot Number: 22JDB871; fff. ROBOTIC PROSTATE PACK, Item Number: DYNJ52085M, Case UDI/GTIN: 40195327210374, Unit UDI/GTIN: 10195327210373, Lot Number: 22JDB086; ggg. GYN ROBOTIC PACK-LF, Item Number: DYNJ52432J, Case UDI/GTIN: 40195327073979, Unit UDI/GTIN: 10195327073978, Lot Number: 22JDB177; hhh. SCRIPPS SW ROBOTIC PACK, Item Number: DYNJ52564D, Case UDI/GTIN: 40195327176427, Unit UDI/GTIN: 10195327176426, Lot Number: 22HMF120,22HME681,22HME682,22FMB534; iii. GYN LITHOTOMY PACK, Item Number: DYNJ53327A, Case UDI/GTIN: 40889942592938, Unit UDI/GTIN: 10889942592937, Lot Number: 22JMG479; jjj. GYN LAPAROSCOPY PACK, Item Number: DYNJ53631G, Case UDI/GTIN: 40195327145430, Unit UDI/GTIN: 10195327145439, Lot Number: 22IBT104; kkk. DEACONESS PELVIC LAP PACK, Item Number: DYNJ53820A, Case UDI/GTIN: 40195327132188, Unit UDI/GTIN: 10195327132187, Lot Number: 22IBL549; lll. WOMENS ROBOT PACK, Item Number: DYNJ53857A, Case UDI/GTIN: 40193489497664, Unit UDI/GTIN: 10193489497663, Lot Number: 22IBD203; mmm. GYN LAPAROSCOPY PACK-LF, Item Number: DYNJ54367, Case UDI/GTIN: 40889942478881, Unit UDI/GTIN: 10889942478880, Lot Number: 22JMG368; nnn. MAJOR GYN PACK, Item Number: DYNJ55693I, Case UDI/GTIN: 40193489847575, Unit UDI/GTIN: 10193489847574, Lot Number: 22IBL365; ooo. GYN LAPAROSCOPY PACK, Item Number: DYNJ56441, Case UDI/GTIN: 40889942646426, Unit UDI/GTIN: 10889942646425, Lot Number: 22HBH543; ppp. TUBAL PACK-LF, Item Number: DYNJ56657, Case UDI/GTIN: 40889942666271, Unit UDI/GTIN: 10889942666270, Lot Number: 22IMB764; qqq. PK, GYN-LAPAROSCOPY, Item Number: DYNJ57609B, Case UDI/GTIN: 40195327244577, Unit UDI/GTIN: 10195327244576, Lot Number: 22IMI129; rrr. LAVH PACK, Item Number: DYNJ57740, Case UDI/GTIN: 40889942773689, Unit UDI/GTIN: 10889942773688, Lot Number: 22IBL578; sss. LAPAROTOMY PACK, Item Number: DYNJ59079D, Case UDI/GTIN: 40195327200252, Unit UDI/GTIN: 10195327200251, Lot Number: 22JBC271,22HBF903; ttt. URO/GEN ROBOTIC PACK, Item Number: DYNJ60803J, Case UDI/GTIN: 40195327138821, Unit UDI/GTIN: 10195327138820, Lot Number: 22KDA153,22IDA962; uuu. BASIC ROBOTIC PACK, Item Number: DYNJ62750B, Case UDI/GTIN: 40193489975858, Unit UDI/GTIN: 10193489975857, Lot Number: 22KBC719,22HBV643,22HBI644; vvv. LAPAROSCOPIC GYN PACK, Item Number: DYNJ62831B, Case UDI/GTIN: 40193489887274, Unit UDI/GTIN: 10193489887273, Lot Number: 22JDC183; www. PK, ROBOTICS-GYN, Item Number: DYNJ63445B, Case UDI/GTIN: 40193489318396, Unit UDI/GTIN: 10193489318395, Lot Number: 22JBC766,22IBI894; xxx. PQ CHG CTRY GYN LAP PK, Item Number: DYNJ64039A, Case UDI/GTIN: 40195327263585, Unit UDI/GTIN: 10195327263584, Lot Number: 22JMC821; yyy. GYN DAVINCI PACK, Item Number: DYNJ64266, Case UDI/GTIN: 40193489795517, Unit UDI/GTIN: 10193489795516, Lot Number: 22JDB068; zzz. ROBOT GYN SHARED, Item Number: DYNJ64793B, Case UDI/GTIN: 40195327217915, Unit UDI/GTIN: 10195327217914, Lot Number: 22JDA845,22HDC106; aaaa. PK, ROBOTICS-GEN, Item Number: DYNJ65193A, Case UDI/GTIN: 40195327244584, Unit UDI/GTIN: 10195327244583, Lot Number: 22IMH017; bbbb. DAVINCI PACK, Item Number: DYNJ66298D, Case UDI/GTIN: 40195327095896, Unit UDI/GTIN: 10195327095895, Lot Number: 22JBQ463; cccc. ROBOTIC GYN PACK, Item Number: DYNJ68688A, Case UDI/GTIN: 40195327095872, Unit UDI/GTIN: 10195327095871, Lot Number: 22JBK548; dddd. ROBOTICS PACK, Item Number: DYNJ69869, Case UDI/GTIN: 40193489992244, Unit UDI/GTIN: 10193489992243, Lot Number: 22HBY203; eeee. PK- ROBOTICS, Item Number: DYNJ69869A, Case UDI/GTIN: 40195327252558, Unit UDI/GTIN: 10195327252557, Lot Number: 22JBL867; ffff. GYN LAPAROSCOPY, Item Number: DYNJ69893A, Case UDI/GTIN: 40195327235018, Unit UDI/GTIN: 10195327235017, Lot Number: 22JBC621,22IBI272; gggg. GU ROBOTIC PACK, Item Number: DYNJ82464, Case UDI/GTIN: 40195327197187, Unit UDI/GTIN: 10195327197186, Lot Number: 22HBJ903; hhhh. GYN PACK, Item Number: DYNJ82488, Case UDI/GTIN: 40195327197446, Unit UDI/GTIN: 10195327197445, Lot Number: 22HBJ906; iiii. BASIC GYN PACK, Item Number: DYNJ82505, Case UDI/GTIN: 40195327198306, Unit UDI/GTIN: 10195327198305, Lot Number: 22HBI366; jjjj. BWH GYN ROBOTICS PACK, Item Number: DYNJ82559, Case UDI/GTIN: 40195327197958, Unit UDI/GTIN: 10195327197957, Lot Number: 22HBQ038; kkkk. BWH GU ROBOTICS PACK, Item Number: DYNJ82560, Case UDI/GTIN: 40195327197965, Unit UDI/GTIN: 10195327197964, Lot Number: 22HBQ039; llll. URO GYN PACK, Item Number: DYNJ82621, Case UDI/GTIN: 40195327199075, Unit UDI/GTIN: 10195327199074, Lot Number: 22HBT063; mmmm. GYN LAP PACK, Item Number: DYNJ82624, Case UDI/GTIN: 40195327199105, Unit UDI/GTIN: 10195327199104, Lot Number: 22HBN265; nnnn. GYN LAPAROSCOPY, Item Number: DYNJ900262, Case UDI/GTIN: 40888277206473, Unit UDI/GTIN: 10888277206472, Lot Number: 22JBR395,22IBT179; oooo. ROBOTIC, Item Number: DYNJ900524K, Case UDI/GTIN: 40193489995290, Unit UDI/GTIN: 10193489995299, Lot Number: 22JDB906,22IDA179; pppp. GYN ROBOTIC, Item Number: DYNJ901046G, Case UDI/GTIN: 40193489820967, Unit UDI/GTIN: 10193489820966, Lot Number: 22JBW050; qqqq. CV ROBOTIC SET UP, Item Number: DYNJ901082C, Case UDI/GTIN: 40193489927659, Unit UDI/GTIN: 10193489927658, Lot Number: 22JBD190,22IBV320; rrrr. GYN LAPAROSCOPY, Item Number: DYNJ901208C, Case UDI/GTIN: 40193489313636, Unit UDI/GTIN: 10193489313635, Lot Number: 22KBF260; ssss. ROBOTIC LAVH, Item Number: DYNJ901281F, Case UDI/GTIN: 40193489961158, Unit UDI/GTIN: 10193489961157, Lot Number: 22IBQ970; tttt. ROBOTIC LAP CHOLE, Item Number: DYNJ901282I, Case UDI/GTIN: 40193489961165, Unit UDI/GTIN: 10193489961164, Lot Number: 22JBI004,22IBT626; uuuu. GYN LAPAROSCOPY, Item Number: DYNJ901370J, Case UDI/GTIN: 40195327245451, Unit UDI/GTIN: 10195327245450, Lot Number: 22JBR464; vvvv. GYN LAPAROSCOPY, Item Number: DYNJ901774F, Case UDI/GTIN: 40193489945677, Unit UDI/GTIN: 10193489945676, Lot Number: 22JBX890,22JBA940; wwww. GYN ROBOTIC, Item Number: DYNJ901796K, Case UDI/GTIN: 40193489979702, Unit UDI/GTIN: 10193489979701, Lot Number: 22IBD418; xxxx. GYN ENDOSCOPY-LF, Item Number: DYNJ901812J, Case UDI/GTIN: 40193489814164, Unit UDI/GTIN: 10193489814163, Lot Number: 22JDB621,22JDA090; yyyy. GYN LAPAROSCOPY, Item Number: DYNJ902371I, Case UDI/GTIN: 40195327223459, Unit UDI/GTIN: 10195327223458, Lot Number: 22KBH351; zzzz. LAP ROBOTIC, Item Number: DYNJ902384J, Case UDI/GTIN: 40193489978088, Unit UDI/GTIN: 10193489978087, Lot Number: 22JBD080; aaaaa. TUBAL LIGATION CDS, Item Number: DYNJ902721D, Case UDI/GTIN: 40193489907927, Unit UDI/GTIN: 10193489907926, Lot Number: 22JBW509; bbbbb. GYN LAPAROSCOPY, Item Number: DYNJ903422F, Case UDI/GTIN: 40193489700320, Unit UDI/GTIN: 10193489700329, Lot Number: 22KBF386,22JBN707; ccccc. ROBOTIC GYN & GU, Item Number: DYNJ903459F, Case UDI/GTIN: 40195327200375, Unit UDI/GTIN: 10195327200374, Lot Number: 22IBD806,22IBE664; ddddd. ROBOTIC, Item Number: DYNJ903485G, Case UDI/GTIN: 40195327172528, Unit UDI/GTIN: 10195327172527, Lot Number: 22JDB549; eeeee. GYN LAPAROSCOPY, Item Number: DYNJ903812C, Case UDI/GTIN: 40193489274111, Unit UDI/GTIN: 10193489274110, Lot Number: 22JBH771,22JBH772; fffff. ROBOT GYN, Item Number: DYNJ904709F, Case UDI/GTIN: 40195327159963, Unit UDI/GTIN: 10195327159962, Lot Number: 22JBW052; ggggg. GYN LAPAROSCOPY, Item Number: DYNJ904713A, Case UDI/GTIN: 40193489674300, Unit UDI/GTIN: 10193489674309, Lot Number: 22JBX929,22JBE278; hhhhh. FHWC ROBOTIC, Item Number: DYNJ905195F, Case UDI/GTIN: 40195327216482, Unit UDI/GTIN: 10195327216481, Lot Number: 22IBQ982; iiiii. GYN LAPAROSCOPY, Item Number: DYNJ905797B, Case UDI/GTIN: 40193489800815, Unit UDI/GTIN: 10193489800814, Lot Number: 22JMC890; jjjjj. GYN LAPAROSCOPY, Item Number: DYNJ906120C, Case UDI/GTIN: 40195327223701, Unit UDI/GTIN: 10195327223700, Lot Number: 22JDB406; kkkkk. ROBOTIC, Item Number: DYNJ906508B, Case UDI/GTIN: 40195327026524, Unit UDI/GTIN: 10195327026523, Lot Number: 22JMD368; lllll. PELVISCOPY, Item Number: DYNJ906536A, Case UDI/GTIN: 40193489815055, Unit UDI/GTIN: 10193489815054, Lot Number: 22KBB847,22KBA201; mmmmm. GENERAL ROBOT-TCN, Item Number: DYNJ906552D, Case UDI/GTIN: 40195327144860, Unit UDI/GTIN: 10195327144869, Lot Number: 22KBH170,22IBU705,22IBA547; nnnnn. ROBOTICS, Item Number: DYNJ906683B, Case UDI/GTIN: 40195327225705, Unit UDI/GTIN: 10195327225704, Lot Number: 22JBR762; ooooo. CVOR ROBOT, Item Number: DYNJ906692A, Case UDI/GTIN: 40195327061532, Unit UDI/GTIN: 10195327061531, Lot Number: 22IBT518; ppppp. GU-GEN ROBOTIC, Item Number: DYNJ906876C, Case UDI/GTIN: 40195327110681, Unit UDI/GTIN: 10195327110680, Lot Number: 22JBD052,22JBB138; qqqqq. FLOYD LAP GYN, Item Number: DYNJ906931C, Case UDI/GTIN: 40193489921299, Unit UDI/GTIN: 10193489921298, Lot Number: 22KBE721,22KBB791,22JBA952; rrrrr. GYN ROBOTIC, Item Number: DYNJ907492D, Case UDI/GTIN: 40195327247462, Unit UDI/GTIN: 10195327247461, Lot Number: 22JBA125; sssss. GYN LAPAROSCOPY CDS, Item Number: DYNJ907841A, Case UDI/GTIN: 40195327018321, Unit UDI/GTIN: 10195327018320, Lot Number: 22JBO683; ttttt. LAP TUBAL, Item Number: DYNJ907883A, Case UDI/GTIN: 40195327019151, Unit UDI/GTIN: 10195327019150, Lot Number: 22KBH354,22JBO108; uuuuu. DAVINCI GENERAL, Item Number: DYNJ908477A, Case UDI/GTIN: 40195327191925, Unit UDI/GTIN: 10195327191924, Lot Number: 22JMG912,22JMF336; vvvvv. DAVINCI LOW ANTERIOR RESECTION, Item Number: DYNJ908479A, Case UDI/GTIN: 40195327192021, Unit UDI/GTIN: 10195327192020, Lot Number: 22JBQ504; wwwww. GYN, Item Number: DYNJ908504A, Case UDI/GTIN: 40195327251292, Unit UDI/GTIN: 10195327251291, Lot Number: 22JBR467,22JBR815; xxxxx. PELVISCOPY PACK, Item Number: DYNJT2136M, Case UDI/GTIN: 40195327109067, Unit UDI/GTIN: 10195327109066, Lot Number: 22IME712; yyyyy. GYN LAPAROSCOPY STD PACK-LF, Item Number: PHS38678001B, Case UDI/GTIN: 40193489636612, Unit UDI/GTIN: 10193489636611, Lot Number: 22HBX127; zzzzz. LAP GYN PACK-LF, Item Number: PHS988229I, Case UDI/GTIN: 40193489766036, Unit UDI/GTIN: 10193489766035, Lot Number: 22JMG416,22IME802
Other Recalls from MEDLINE INDUSTRIES, LP - Northfield
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2567-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2566-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2479-2025 | Class II | Medline Kits containing BD SureStep Foley Tray ... | Jul 23, 2025 |
| Z-2460-2025 | Class I | Medline ReNewal Reprocessed St. Jude Medical Re... | Jul 14, 2025 |
| Z-2452-2025 | Class II | The Medline General Surgery Tray is customized ... | Jul 8, 2025 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.